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NCT06388863

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
Shanghai Zhongshan Hospital·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Parkinson Disease
Drug/Device/Intervention
Healthy donor-derived FMT capsule
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Zhongshan Hospital
Location
Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
May 31, 2026
Enrollment
76 participants
Primary outcome

Response rate of constipation in Parkinson's Disease (PD)

Summary

Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For
 interventional group, patients will be given six FMT capsules twice a week for 24 weeks.
 Placebo capsules are identical in appearance and smell but contain milk powder. At each
 follow-up visits, participants complete specific scales to assess improvement in
 constipation, emotion and quality of life. Besides, fecal samples are collected for
 metagenomics and metabolomics sequencing and blood samples are tested peripheral
 concentration of levodopa.

ICD-10 classifications
Parkinson diseaseParkinsonism in diseases classified elsewhereDementia in Parkinson diseaseSecondary parkinsonismSecondary parkinsonism, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06388863
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06388863 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Zhongshan Hospital and is currently Not yet recruiting. The study focuses on Parkinson Disease. Target enrollment is 76 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.